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NCT03988842: SAFE-LYSE
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism
Phase 4 trial testing Alteplase in Pulmonary Embolism With Acute Cor Pulmonale in 4 participants. Terminated before completion.
5 April 2020
Quick facts
| Lead sponsor | Victor Tapson, MD |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 25 July 2019 |
| Primary completion | 5 April 2020 |
| Estimated completion | 5 April 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alteplase (ALTEPLASE) — full drug profile →
- Unfractionated heparin — full drug profile →
- Placebo
- Apixaban (apixaban) — full drug profile →
Conditions studied
- Pulmonary Embolism With Acute Cor Pulmonale — all drugs for Pulmonary Embolism With Acute Cor Pulmonale →
- Pulmonary Embolism — all drugs for Pulmonary Embolism →
- Pulmonary Embolism With Pulmonary Infarction — all drugs for Pulmonary Embolism With Pulmonary Infarction →
- Pulmonary Embolism Subacute Massive — all drugs for Pulmonary Embolism Subacute Massive →
Sponsor
Victor Tapson, MD
Who can join
Adults 18 to 75, any sex, with Pulmonary Embolism With Acute Cor Pulmonale or Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected up to 8.5months given patient safety concerns due to the COVID-19 pandemic. The original Adverse Event assessment per the protocol was 1 year from baseline.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | All Study Participants |
|---|---|---|
| AKI and Anemia | Renal and urinary disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
Other adverse events (14 terms — click to expand)
| Reaction | System | All Study Participants |
|---|---|---|
| Headache | Nervous system disorders | — |
| Eye pain | Eye disorders | — |
| Stomach pain | Gastrointestinal disorders | — |
| Suspected bleed | Blood and lymphatic system disorders | — |
| Bruising on chest | Blood and lymphatic system disorders | — |
| increased shortness of breath | Respiratory, thoracic and mediastinal disorders | — |
| Suspected bleed | Blood and lymphatic system disorders | — |
| back pain | Musculoskeletal and connective tissue disorders | — |
| Suspected bleed | Blood and lymphatic system disorders | — |
| worsening back pain | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| left groin pain | Musculoskeletal and connective tissue disorders | — |
| palpitations | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: AKI and Anemia, Respiratory Failure, Anemia.
Data from ClinicalTrials.gov NCT03988842 adverse events section.
Sponsor's own description
The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Thrombolytic therapy for pulmonary embolism.
Zuo Z, Yue J, Dong BR, Wu T, et al · · 2021 · cited 27× · PMID 33857326 · DOI 10.1002/14651858.cd004437.pub6
Verify or expand the search:
- PubMed search for NCT03988842
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alteplase
Trials testing the same drug.
- NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke · Phase 3 · recruiting
- NCT07003646 — Reperfusion Treatment in Acute Pulmonary Embolism · recruiting
- NCT07360717 — To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion · NA · completed
- NCT06621121 — A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Strok · recruiting
- NCT06194968 — Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study · recruiting
Other recruiting trials for Pulmonary Embolism With Acute Cor Pulmonale
Currently open trials in the same condition.
- NCT07491094 — Repeated Examinations for Typing Pulmonary Embolism · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03988842 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Victor Tapson, MD
- Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03988842.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing